In recent years as the problem of tansmissible diseases, such as AIDS, escalating, the need for safe intravenous fluid administration systems, which can prevent health care personnel from accidental needle injuries, is strongly felt among health care providers and researchers. In practice there are three most common situations where intravenous fluid administration systems are used.
The first is where an open end of a catheter is introduced into a vein in a patient's arm, and the other end of the catheter is outside the patient and closed by an injection cap with a needle-penetrable self-sealing injection port. The injection cap is secured on the patient's skin by taping. Fluids can be withdrawn or supplied through a needle that penetrates the injection port. The needle is connected to a syringe or to one end of a tubing with a fluid source supplied at the other end. This set up is called a periphery line.
The second is where an open end of a catheter is introduced into a vein in a patient's arm, and the other end is outside the patient and connected to one end of a tubing with a primary fluid source continuously supplied at the other end. Along the tubing there are constructed a number of injection sites. The injection sites are usually in the form of a short side branches of hard tubes connected to the main tubing and closed by needle-penetrable self-sealing injection ports. The injection ports are called Y-injection sites. Additional fluids can be withdrawn or supplied through a needle that penetrates the injection port of one of the Y-injection site. The needle is connected to a syringe or to one end of a tubing with a secondary fluid source supplied at the other end.
The third is where an open end of a catheter with one or more lumens is inserted into a vein in a patient's chest and the catheter is sutured to the patient's skin. Each branch of the lumen, if there are more than one, is outside the patient and closed by an injection cap with a needle-penetrable self-sealing injection port. Fluids can be withdrawn or supplied through a needle that penetrates inside the injection port. The needle is connected to a syringe or to one end of a tubing with a fluid source supplied at another end. This set up is called a central line.
In the aforementioned and other situations, because needles are used to connect catheters and fluid supply sources, health care personnel who handle those fluid administration systems are exposed to the danger of contracting tansmissible diseases, such as AIDS, from accidental needle injuries. Another problem with the needle connection is that the needle and the injection cap must be taped together to ensure a good connection. Extra precautions must be taken in taping, since the connection can often get loose, on the other hand if the taping is too tight, it becomes very difficult to disconnect. There have been several previous attempts to develop safety devices in intravenous fluid administration systems with limited success.
One such tubing connector is disclosed in U.S. Pat. No. 4,964,855. It can lock with the side branch of a Y-injection site, but can not be used on central lines and periphery lines.
Another tubing connector is disclosed in U.S. Pat. No. 4,834,716. It can be fitted but can not be locked on a Y-injection site. Taping is still required to secure the connection. This connector can not be used on periphery lines.
A combination of an tubing connector and an injection cap is disclosed in U.S. Pat. No. 4,950,260. Since the locking arrangement prevents taping of the injection cap to a patient's skin, this set can not be used on periphery lines without an additional extension tubing.
Another combination of a tubing connector and an injection cap, Called Kleen-Needle System, is made by Tri-State Hospital Supply Corp. of Howell, MI 48843. The tubing connector can be locked onto the injection cap by matching screw threads on the outside of the injection cap and on the inside of the needle sheath of the tubing connector. After the injection cap being taped on a patient's skin it is difficult to make a locking engagement, so this set is inconvenient for use on periphery lines without an additional extension tubing.
Still another combination of a tubing connector and an injection cap is disclosed in U.S. Pat. No. 4,752,292. Since the locking mechanism on the tubing connector prevent the injection cap being taped on a patient, it can not be used on a periphery line without an additional extension tubing.
Baxter health care Corporation of Deerfield, IL 60015 has made a Needle-Less System including an injection cap and a tubing connector. On the tubing connector a sharp needle is replaced by a large diameter blunt plastic cannula. When forced into the injection port the plastic cannula makes a large puncture on the injection port. This puts a very high demand on the self-sealing property of the injection port. In practice the injection port may not work very well.
The safety devices so far, while they work under certain situations, all have some limitations on their applicability and some inconveniences in their usage. The additional extension tubing on the injection cap in some of the prior art, for example, not only increases the cost, it also requires extra steps of purging air from the tubing and taping the tubing on a patient. There exists a need for safety intravenous fluid administration systems which can be interchangeably used in different applications. Particularly there is a need for the combination of injection caps and tubing connectors which can be easily and reliably used on periphery lines.
It is one object of the invention to provide an improved safe injection cap that includes a locking lug for positively locking the connection with a tubing connector.
Another object of the present invention is to provide an improved safe injection cap that includes an attachment wing for securely fastening the injection cap to a patient.
Still another object of the present invention is to provide an improved safe Y-injection site that includes a locking lug for positively locking the connection with a tubing connector.
Yet another object of the invention is to provide an improved safe tubing connector that can be interchangeably used on the improved injection caps and Y-injection sites.
Yet another object of the invention is to provide an improved safe tubing connector that can be connected and disconnected with minimum manipulation.
Yet another object of the present invention is to provide an improved safe tubing connector for an injection site built on a container, an I.V. line, and the like to safely remove or supply fluids.
Yet another object of the present invention is to provide an improved safe injection needles with a protective sheath for an injection site built on a container, an I.V. line, and the like to safely remove or supply fluids.
Yet another object of the present invention is to provide an improved container with built-in injection site for a sheathed injection needle or a tubing connector to remove fluid from the container.
Yet another object of the present invention is to provide a combination of injection caps and tubing connectors which can be easily and reliably used on periphery lines.
Yet another object of the present invention is to provide a safe parenteral fluid administration system that including an improved injection cap, Y-injection site, tubing connector, sheathed injection needle and container with a built-in injection site, which can protect its user from inadvertent needle injuries in almost all common applications.